Your MDR Strategy: Start with a Gap Analysis

The 566-page Medical Device Regulation (MDR), which replaces the EU’s Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC), has caused much discussion, training, debate, and stress in the medical device industry since its publication in May 2017. To say nothing of the changes in device regulation, the aggressive three-year implementation goal of May 26, 2020 has the industry as a whole — manufacturers, laboratories, and regulators — strategizing diligently as we step into 2020. This article briefly examines the current state of the MDR, including deadline extensions announced in the second corrigenda, a strategy to address material information, and what should be included in a gap analysis.